TAVR BIOCOMPATIBILITY STUDIES
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Regulatory and Quality Affairs: Answers to FDA and ISO Gray Areas
The document discusses regulatory gray areas and provides examples of how experts navigate ambiguous requirements. It addresses topics like complaints, clinical evaluation reports, unique device identification, and validation sample sizes. For complaints, it provides case examples and discusses when to investigate and report. For clinical evaluation reports, it discusses author credentials and responding when not all indications have data. For unique device identification, it discusses applicability based on size. For validation, it discusses sample size requirements and working with suppliers. Finally, it discusses supplier relationships and appropriate handling of defects. The key takeaway is that communication, documentation, and asking for help can aid in navigating regulatory uncertainties.
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Versatile & goal-oriented professional with over 4 .5 Years of experience in managing Product quality, customer handling in Quality(QA&QC)
Quality assurance activities, development of processes to ensure the good quality product by PPAP,FMEA,SPC,Control Plan activities
Application of 7 QC Tools, 8D and 5 Why methodologies for analysis of rejections.
Developing a framework of quality standards, procedures & systems and overseeing smooth implementation in shop floor and at supplier end.
Why Does FDA Need Standards For In Vitro Diagnostic Devices
FDA standards for in vitro diagnostic devices (IVDs) are necessary to ensure their quality, safety, and effectiveness. Title 21 of the Code of Federal Regulations Part 820 contains quality system regulations that IVD manufacturers must comply with. These regulations require that IVD design, production, and distribution be carried out in a controlled and documented manner. While the regulations provide clarity for approval processes, novel IVD technologies may require pre-submission engagement with FDA to determine regulatory pathways. Overall, following IVD standards and engaging in dialogue with FDA can help manufacturers successfully achieve regulatory approval.
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Nondestructive testing
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Atul_CV_(1)
Atul Borse has over 4 years of experience in quality control and quality assurance. He has a Master's degree in Analytical Chemistry and is proficient in using instruments like HPLC, GC, FTIR, and UV spectrophotometers. Currently he works as an executive in quality assurance at Johnson & Johnson Ltd. where he handles market complaints and ensures compliance with quality standards. Previously he has worked for other pharmaceutical companies like Wockhardt and Ajanta Pharmaceuticals in roles with increasing responsibility. He is skilled in documentation management, audits, and ensuring compliance with GMP, ISO, and regulatory guidelines.
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Thiruneelakandan Gnanasambandan is seeking a challenging position in pharmaceuticals, medical devices, healthcare, or biosciences to utilize his skills in product and method development. He has over 5 years of experience in quality control and R&D, specializing in analytical method validation and transfer. He is skilled in HPLC, GC, UV, and titration methods and has experience managing quality teams and ensuring regulatory compliance. His most recent roles include method transfer specialist and quality control head at pharmaceutical companies in Singapore.
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We all know how much emphasis FDA inspectors and ISO auditors place on your customer complaint and CAPA processes. And rightfully so.
But what if there were things you could do to minimize the struggles and challenges associated with customer complaint and CAPA management?
Good news. You can decrease the number of customer complaints and reduce the volume of issued CAPAs through good product development Design Controls and Risk Management practices.
Specifically this presentation will cover:
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Regulatory and Quality Affairs: Answers to FDA and ISO Gray Areas
The document discusses regulatory gray areas and provides examples of how experts navigate ambiguous requirements. It addresses topics like complaints, clinical evaluation reports, unique device identification, and validation sample sizes. For complaints, it provides case examples and discusses when to investigate and report. For clinical evaluation reports, it discusses author credentials and responding when not all indications have data. For unique device identification, it discusses applicability based on size. For validation, it discusses sample size requirements and working with suppliers. Finally, it discusses supplier relationships and appropriate handling of defects. The key takeaway is that communication, documentation, and asking for help can aid in navigating regulatory uncertainties.
Resume
Versatile & goal-oriented professional with over 4 .5 Years of experience in managing Product quality, customer handling in Quality(QA&QC)
Quality assurance activities, development of processes to ensure the good quality product by PPAP,FMEA,SPC,Control Plan activities
Application of 7 QC Tools, 8D and 5 Why methodologies for analysis of rejections.
Developing a framework of quality standards, procedures & systems and overseeing smooth implementation in shop floor and at supplier end.
Why Does FDA Need Standards For In Vitro Diagnostic Devices
FDA standards for in vitro diagnostic devices (IVDs) are necessary to ensure their quality, safety, and effectiveness. Title 21 of the Code of Federal Regulations Part 820 contains quality system regulations that IVD manufacturers must comply with. These regulations require that IVD design, production, and distribution be carried out in a controlled and documented manner. While the regulations provide clarity for approval processes, novel IVD technologies may require pre-submission engagement with FDA to determine regulatory pathways. Overall, following IVD standards and engaging in dialogue with FDA can help manufacturers successfully achieve regulatory approval.
TPRG - Third Party Review Group
FDA Third Party Review Specialists
It takes one-third of the time to reach a 510K approval with TPRG - 55 days via 160 days. 510(k) in Calendar Days
You are welcome to call their epesenttive to the region
Nondestructive testing
AGC Aerospace & Defense is a company focused on providing efficient solutions to the aerospace industry through its 10+ constituent companies. One method it employs is nondestructive testing (NDT), which involves inspecting items or processes under critical conditions without damage through techniques like ultrasonic, dye penetrant, and eddy-current testing. NDT allows for gathering information that destructive testing cannot by avoiding the need for reconstruction and repairs.
Atul_CV_(1)
Atul Borse has over 4 years of experience in quality control and quality assurance. He has a Master's degree in Analytical Chemistry and is proficient in using instruments like HPLC, GC, FTIR, and UV spectrophotometers. Currently he works as an executive in quality assurance at Johnson & Johnson Ltd. where he handles market complaints and ensures compliance with quality standards. Previously he has worked for other pharmaceutical companies like Wockhardt and Ajanta Pharmaceuticals in roles with increasing responsibility. He is skilled in documentation management, audits, and ensuring compliance with GMP, ISO, and regulatory guidelines.
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Thiruneelakandan Gnanasambandan is seeking a challenging position in pharmaceuticals, medical devices, healthcare, or biosciences to utilize his skills in product and method development. He has over 5 years of experience in quality control and R&D, specializing in analytical method validation and transfer. He is skilled in HPLC, GC, UV, and titration methods and has experience managing quality teams and ensuring regulatory compliance. His most recent roles include method transfer specialist and quality control head at pharmaceutical companies in Singapore.
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We all know how much emphasis FDA inspectors and ISO auditors place on your customer complaint and CAPA processes. And rightfully so.
But what if there were things you could do to minimize the struggles and challenges associated with customer complaint and CAPA management?
Good news. You can decrease the number of customer complaints and reduce the volume of issued CAPAs through good product development Design Controls and Risk Management practices.
Specifically this presentation will cover:
-Influence Design Controls has on Customer Complaints
-How Customer Complaints impact your CAPA system
-Best practices for Design Controls
-Best practices for Risk Management
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How long has it been since your last FDA inspection?
You know FDA is technically mandated to inspect any company with class II or class III products every two years (and inspections have been on the rise particularly for foreign / outside the US firms).
If FDA called tomorrow to announce their plans to visit your facility next week would you be prepared?
Even the most prepared companies still often find themselves receiving 483 observations.
Then you must act swiftly and effectively to avoid that observation escalating to a warning letter.
But what exactly do you do?
How do you respond to FDA 483 observations and/or warning letters?
greenlight.guru founder and VP QA/RA, Jon Speer, has been through his fair share of FDA inspections over the course of his 17+ year career in the medical device industry and has helped many of companies respond to 483 observations and warning letters along the way.
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What you should be doing to always be prepared for an FDA inspection
How to help prep your team before an FDA inspection
The top 7 reasons FDA issued medical device companies 483 observations and warning letters in FY2015
Tips you can implement today to mitigate your risk of getting 483’s and warning letters
What you need to do before responding to a 483 to minimize the damage (and avoid the common pitfalls)
Best practices for responding to FDA 483 and warning letter (including a free response template)
The differences in responding to a 483 observation vs. a warning letter
What to expect from FDA after submitting your response
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The document discusses the importance of developing clear and measurable product requirements for medical devices to gain regulatory approval. It states that product requirements should articulate the product's purpose, features, functionality and behavior. Each requirement must be testable and measurable to aid in the verification and validation process required for regulatory submission. The marketing requirements document provides an overview of market need while the product requirements document specifies all technical requirements for the device to ensure it is designed correctly to meet customer needs.
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Product certification or product qualification is the process of certifying that a certain
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qualification criteria stipulated in contracts, regulations, or specifications (sometimes
called "certification schemes" in the product certification industry).
Most product certification bodies (or product certifiers) are accredited to or aligned with
ISO/IEC 17065 Conformity assessment -- Requirements for bodies certifying products,
processes and services (previously ISO/IEC Guide 65:1996) an international standard
for ensuring competence in those organizations performing product, process and service
certifications. The organizations that perform this accreditation are called Accreditation
Bodies, and they themselves are assessed by international peers against the ISO 17011
standard. In India Product certification is being monitored by BUREAU OF INDIAN
STANDARDS.
Examples of some certification schemes include the Safety Equipment Institute for
protective headgear, the U.S. Federal Communications Commission (FCC)
Telecommunication Certification Body (TCB) program for radio communication devices,
the U.S. Environmental Protection Agency Energy Star program, the International
Commission on the Rules for the Approval of Electrical Equipment Product Safety
Certification Body Scheme (IEECE CB Scheme), MAS (Materials Analytical Services)
Certified Green IEQ program, and the Greenguard Environmental Institute Indoor Air
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Alyante’s array of innovation-based services and commitment to excellence will help you create new value.
Alyante is an assurance of an alliance that strives to keep your research always ahead of the competition through innovation and trust.
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Leverage Computational Modeling and Simulation for Device Design - OMTEC 2017
Computational modeling and simulation (CM&S) has the potential to revolutionize medical devices by accelerating innovation and providing comprehensive evidence of long-term safety. For example, CM&S can provide performance benchmarks, assess design parameter interdependencies, evaluate a variety of use conditions, provide visualization of complex processes and become a core element of device submissions and approvals. This presentation will begin with an overview of the use of CM&S throughout the orthopaedic implant lifecycle, followed by a review of the current regulatory direction regarding the use of CM&S in device submissions. Next, a series of case studies based on a variety of orthopaedic implants will demonstrate the application of CM&S at various phases of the product lifecycle in more detail. The examples will also highlight the effects of modeling assumptions on model credibility and some verification and validation best practices.
This presentation will position CM&S as a credible and common means for device companies and FDA to demonstrate the safety of medical devices, and thereby ensure safety, reduce cost and accelerate the pathway toward “first in the world” access to products in the U.S.
How to Prepare for an FDA Inspection and Respond to FDA 483's / Warning Letters
How long has it been since your last FDA inspection?
You know FDA is technically mandated to inspect any company with class II or class III products every two years (and inspections have been on the rise particularly for foreign / outside the US firms).
If FDA called tomorrow to announce their plans to visit your facility next week would you be prepared?
Even the most prepared companies still often find themselves receiving 483 observations.
Then you must act swiftly and effectively to avoid that observation escalating to a warning letter.
But what exactly do you do?
How do you respond to FDA 483 observations and/or warning letters?
greenlight.guru founder and VP QA/RA, Jon Speer, has been through his fair share of FDA inspections over the course of his 17+ year career in the medical device industry and has helped many of companies respond to 483 observations and warning letters along the way.
In this free, 60 minutes webinar, Jon will be sharing his most effective tips on how to avoid 483’s and warning letters in the first place along with a step-by-step guide to responding the them if you do happen to receive either.
(You can view the full webinar here: http://www.greenlight.guru/webinar/fda-483-warning-letter-response)
Specifically you'll learn:
What you should be doing to always be prepared for an FDA inspection
How to help prep your team before an FDA inspection
The top 7 reasons FDA issued medical device companies 483 observations and warning letters in FY2015
Tips you can implement today to mitigate your risk of getting 483’s and warning letters
What you need to do before responding to a 483 to minimize the damage (and avoid the common pitfalls)
Best practices for responding to FDA 483 and warning letter (including a free response template)
The differences in responding to a 483 observation vs. a warning letter
What to expect from FDA after submitting your response
Brochure
Farm is an ISO 13485-certified and FDA-compliant product development consultancy with over 40 years of experience helping medical, life sciences, and consumer healthcare companies. It offers expertise in areas like user research, engineering, design, and regulatory compliance. Farm helps clients design devices that are safe, easy to use and effective by employing research, usability testing, and a process-driven development approach.
Multiplexing and Arraying in Lateral Flow Assays
Lateral flow assays are the most robust, mature immuno sensor available today. Performance in some applications has historically been limited by difficulties in multiplexing and quantification. Novel approaches have been developed and commercialized in recent years that allow for the development and manufacturing of highly multiplexed arrays in lateral flow assays. The patented Symbolics (tm) approach is one such methodology. Symboics (tm) allows for the creation of arrays in lateral flow fields that develop evenly, allowing in turn for the creation of highly complex features such as letters and symbols and also allows for creation of multiplex assays with advanced features such as internal controls. This presentation introduces the principles of multiplexed arraying and the Symbolics technology
NABL Certification
Introduction, preparation required by laboratory, Process of Accreditation, difference between NABL certification and ISO 9000 certification
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Detail Engineering
Third Party inspection
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Consultancy
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Design and development of medical device
The document outlines the key steps in the medical device design and development process as required by ISO 13485. This includes establishing procedures for design and development stages, planning with target dates and reviews, determining inputs, producing outputs like drawings and bills of materials, conducting reviews and verification to ensure outputs meet inputs, performing validation to ensure the product meets requirements, and controlling any changes to the design.
medical devices and invitro diagnosis by rahul sagar, m. pharm(dra), bbau luc...
This presentation provides an overview of medical device validation. It discusses the categories of medical devices and regulatory requirements for validation. The presentation covers validation concepts for medical devices including process validation and risk assessment. Analytical and clinical validation methods are described for in vitro diagnostic tests. Finally, the FDA regulatory perspectives on medical devices based on risk classification are summarized.
Developing Product Requirements For Medical Devices
The document discusses the importance of developing clear and measurable product requirements for medical devices to gain regulatory approval. It states that product requirements should articulate the product's purpose, features, functionality and behavior. Each requirement must be testable and measurable to aid in the verification and validation process required for regulatory submission. The marketing requirements document provides an overview of market need while the product requirements document specifies all technical requirements for the device to ensure it is designed correctly to meet customer needs.
Computational Modeling & Simulation in Orthopedics: Tools to Comply in an Ev...
Computational Modeling & Simulation has the ability to revolutionize the orthopedic device industry by reducing and in some instances eliminating the need for benchtop testing and clinical trials. Dr. Afshari shared his experience in establishing the credibility of computational models for product design and development purposes, and highlighted was that modeling fits with the regulatory and standards framework.
Esperanto for Engineers, Technical Talk for Medical Engineers
Presentation given at the 2012 NPAG Conference in Rugby UK. Some suggestions as to how we can better develop our 'technical talk' and what has already been developed and available.
Marketing II: Indu Isaacs
The document describes the services of a contract development and manufacturing organization called Lowell and Andover. It outlines their capabilities in formulation development, analytical development, manufacturing, and regulatory experience assisting clients from discovery through post-approval. Their goal is meeting expectations for timelines and producing consistent, stable dosage forms to help clients advance products at the speed of science.
Intelligent Automation and Smart Tooling
The intelligent automation strategy and tool selection by STAG reduced testing cycle time by 70% and license costs by 60% for a healthcare IT company. STAG analyzed test artifacts, classified test cases, developed an automation architecture using TestComplete tool, and automated 326 test cases. This robust automation framework cut testing effort from 50 to 12 hours. STAG also trained the client's team, providing additional savings versus outside training costs.
Regulatory Compliance QA
A case study - Implementation of smart test practices improves test coverage by 50% and adherence to regulatory compliance in all product releases enables STAG to gain
the trust and assist in all FDA audit of a leading compliance eLearning solutions provider.
Metallurgy Consultant
The document provides information about Metallurgical Consulting Group - India (MCG), an organization established in 1998 that provides metallurgical consulting services. MCG has experience in various industries including automotive, engineering, glass, and chemical. Their services include technical audits, quality control guidance, cost cutting solutions, material testing labs setup, and problem solving. They have experience in glass mould metallurgy and developing alloys for the glass industry to reduce costs and improve quality.
Responding To A 483and Warning Letter
The document discusses responding to FDA Form 483s and Warning Letters. It provides guidance on responding verbally and in writing to Form 483 observations from FDA inspections. A good written response should acknowledge deficiencies, describe corrective actions and timeframes, and address systemic issues. For Warning Letters, the response should notify top management, discuss corrective actions and timelines, and request a meeting with FDA if needed. Establishing effective quality systems is the best way to avoid enforcement actions.
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Leverage Computational Modeling and Simulation for Device Design - OMTEC 2017
Leverage Computational Modeling and Simulation for Device Design - OMTEC 2017
How to Prepare for an FDA Inspection and Respond to FDA 483's / Warning Letters
How to Prepare for an FDA Inspection and Respond to FDA 483's / Warning Letters
medical devices and invitro diagnosis by rahul sagar, m. pharm(dra), bbau luc...
medical devices and invitro diagnosis by rahul sagar, m. pharm(dra), bbau luc...
Developing Product Requirements For Medical Devices
Developing Product Requirements For Medical Devices
Computational Modeling & Simulation in Orthopedics: Tools to Comply in an Ev...
Computational Modeling & Simulation in Orthopedics: Tools to Comply in an Ev...
Esperanto for Engineers, Technical Talk for Medical Engineers
Esperanto for Engineers, Technical Talk for Medical Engineers
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ISO 17065 .pdf
Product certification or product qualification is the process of certifying that a certain
product has passed performance tests and quality assurance tests, and meets
qualification criteria stipulated in contracts, regulations, or specifications (sometimes
called "certification schemes" in the product certification industry).
Most product certification bodies (or product certifiers) are accredited to or aligned with
ISO/IEC 17065 Conformity assessment -- Requirements for bodies certifying products,
processes and services (previously ISO/IEC Guide 65:1996) an international standard
for ensuring competence in those organizations performing product, process and service
certifications. The organizations that perform this accreditation are called Accreditation
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standard. In India Product certification is being monitored by BUREAU OF INDIAN
STANDARDS.
Examples of some certification schemes include the Safety Equipment Institute for
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Commission on the Rules for the Approval of Electrical Equipment Product Safety
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Missing in the above two items is an expression of HOW WELL YOU DO WHAT YOU DO? This is where you must establish your “Systems Validation Protocol” (SVP). Your SVP is an expression of how well your system is working (for example, this can be expressed in overall product conformance percentage or in defects per million for your various products). The SVP is a living and continuous document based on your quality records. The ATL White Paper “What Are The Systems Validation Protocol Methods At ATL?” is our attempt to share with you a sound approach to Systems Validation and the various protocols that you can use.
Ruud Cox - Testing in a Medical Device Context - EuroSTAR 2012
EuroSTAR Software Testing Conference 2012 presentation on Testing in a Medical Device Context by Ruud Cox. See more at: http://conference.eurostarsoftwaretesting.com/past-presentations/
Progamma Us
ProGammaScience Corporation is a consulting firm based in Montreal that has been providing quality assurance, regulatory affairs, and technical operations services to the pharmaceutical industry since 1985, including assistance with submissions, GMP compliance, analytical method validation, product development, and technical training. The company aims to deliver excellent client service and documentation support at the best possible cost through its team of qualified professionals. Some of ProGammaScience's clients include major pharmaceutical companies like Abbott, AstraZeneca, Merck, Novartis, and Pfizer.
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Cpsia
The document provides an overview of new testing and certification requirements under the Consumer Product Safety Improvement Act (CPSIA) as amended by recent legislation. It discusses key provisions including:
- Certification will now be required for products subject to CPSC standards, as enforcement stays have lifted.
- The Component Testing Rule allows certification based on component part testing, but requires extensive documentation.
- The new Testing and Certification Rule establishes recordkeeping and periodic testing requirements to provide a "high degree of assurance" of ongoing compliance for children's products. It outlines three options for periodic testing.
- Material changes will require retesting and recertification. Undue influence policies and training are also required.
Quality Auditor and trainerProfile-G.sundar
The document provides a curriculum vitae for G.Sundar outlining his 22 years of experience in quality assurance and regulatory compliance roles. It details his expertise in areas such as GMP, GLP, ISO standards, equipment and process validation, auditing, and preparing for regulatory inspections. It also lists recent regulatory audits he has faced, including multiple successful USFDA inspections, and audits he has conducted of API and formulation manufacturing sites.
Paragon Catalogue 2018
Paragon Scientific Limited specialise in the production of premium quality reference materials that include Density, Flash Point, Liquid Colour, Refractive Index, TAN/TBN and Viscosity standards.
Founded in 1994, Paragon have developed an international reputation synonymous with quality, prompt delivery, affordability, and first class customer service. A combination of advanced manufacturing techniques, the use of Primary laboratory test equipment and acute attention to detail enables Paragons to produce reference materials with some of the lowest levels of uncertainty of measurement available. Paragon's products are used in multiple industries throughout the world.
SMI Talk
The document discusses best practices for in-licensing biosimilars, including technical diligence and contract negotiations. It emphasizes the importance of a thorough scientific diligence process involving outside experts to evaluate analytical data and identify any gaps. Key areas of focus include manufacturing quality, IP status, and addressing any regulatory concerns. The document also recommends structuring deals to mitigate risk through milestone-based payments tied to key development stages. Contract negotiations should protect the licensee's interests regarding supply obligations, liability, termination rights, and exclusivity.
Iso 17025 standard
ISO 17025 is an international standard for testing and calibration laboratories seeking accreditation. It has requirements for management, technical operations, and quality assurance. Accreditation increases confidence in test results, enhances customer satisfaction, and improves laboratory effectiveness through regular inspections. While accreditation requires costs for implementation and maintenance, it also provides benefits like reduced re-testing and an improved reputation. The standard has been adopted by accreditation bodies in several countries including Australia, New Zealand, and India.
Managing Reliability Expectations & Warranty Costs in Medical Electronics
What are ‘medical’ electronics?
Is it a realistic category?
Some implanted in the body; some outside
Some portable; some fixed
Some complex; some simple
Some control; some monitor; some medicate
All connected by the perception that one’s life
may be dependent upon this product
Creates a powerful emotional attachment/effect
Assuring reliability becomes critical
Paragon Scientific: Callibration Standards & Certified Reference Materials
Paragon Scientific Ltd. Founded in 1994, we have developed an international reputation synonymous with quality, prompt delivery,
affordability and first class customer service. We are committed to develop, manufacture and supply the highest quality standards and reference materials available in the marketplace. We believe that this approach combined with key attention to customer service, technical support and prompt delivery is key to our business success.
Pharmaceutical validation
U.S.F.D.A. was the pioneer in the concept of process validation.
Validation had proven to be an important tool for quality management of pharmaceutical according to ISO 9000:2000.
Pharmaceutical validation
U.S.F.D.A. was the pioneer in the concept of process validation.
Validation had proven to be an important tool for quality management of pharmaceutical according to ISO 9000:2000.
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